Training #04

Training in risk management applied to medical devices in accordance with ISO 14971 and benefit/risk management in accordance with XP S99-223

Training methods

Prerequisites

Knowledge of Regulation (EU) 2017/745.

Target audience

People involved in :

Medical device design
Regulatory affairs and quality assurance
Anyone involved in the risk management process

Further information

Location: Face-to-face or distance learning
Date: Tuesday, March 18, 2025
Duration: 1 day (7 hours) or 1.5 days (10h30) depending on prerequisites and requirements

Download the training sheet

Training content

Understand and carry out risk management of your medical devices in accordance with current ISO 14971 to meet the requirements of Regulation (EU) 2017/745.

Post-training evaluation questionnaire
Training satisfaction evaluation questionnaire

Each participant will be able to :

Understand the requirements of the current ISO 14971 standard (Medical devices - Application of risk management to medical devices)
Assessing risks in relation to expected benefits
Know how to conduct risk management in accordance with the current ISO 14971 standard
Know how to draw up a risk management file to meet the requirements of Regulation (EU) 2017/745.

Detailed training schedule
Digital training materials
Training evaluation questionnaires
Results of trainee learning assessment
Training certificate

Risk management terminology and methodology
Contribution of the current ISO/TR 24971 technical standard to meeting requirements
Application of current XP S99-223 standard for benefit/risk management
Interface with Regulation (EU) 2017/745 (covered requirements)

Starting at €980
Price adapted to your needs, number of participants and type of training (inter / intra-company).
Contact us for a personalized quote

Teaching aids (course support presentation, extracts from standards documents, document templates, etc.)
Practical exercises, feedback, case studies based on your system